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A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Trial Status: active
This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell
Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if
BMS-986506 is safe and can be tolerated when taken alone or in combination by
participants with ccRCC.
Inclusion Criteria
Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1/L1 checkpoint inhibitor and/or a VEGF-TKI).
Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
Eastern Cooperative Oncology Group performance status of 0 to 1.
Exclusion Criteria
Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor).
Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody).
Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy.
Other protocol-defined Inclusion/Exclusion criteria apply.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07195682.